Regulatory Actions

Luminex Corporation Receives U.S. Food and Drug Administration Clearance for xTAG(TM) Respiratory Viral Panel

Published in Medical Letter on the CDC and FDA, January 20th, 2008

Luminex Corporation (NASDAQ: LMNX), the worldwide leader in multiplexed solutions, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its xTAG(TM) Respiratory Viral Panel (RVP). xTAG RVP is the first FDA-cleared assay to simultaneously detect and identify 12 viruses and viral subtypes that together are responsible for more than 85 percent of respiratory viral infections.

xTAG RVP is a groundbreaking test that, with a single patient sample, can assess the presence or absence of 12 viral targets and provide qualitative results in a few hours. Traditional testing for this many viruses requires multiple individual diagnostic...

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Source: Medical Letter on the CDC and FDA (2008-01-20)

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